2024
Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans
Yu Q, George S, Kyriakides T, Rhon D, Morasco B, Dziura J, Fritz J, Geda M, Peduzzi P, Long C. Adapting to change: experiences and recommendations from the Pain Management Collaboratory on modifying statistical analysis plans. Pain Medicine 2024, 25: s49-s53. PMID: 39514871, PMCID: PMC11548855, DOI: 10.1093/pm/pnae073.Peer-Reviewed Original ResearchConceptsPragmatic clinical trialsPain Management CollaboratoryStatistical analysis planTrial protocolAnalysis planEvaluate nonpharmacological interventionsNonpharmacological interventionsTrial launchStudy designSecondary outcomesTrials RegistryPrimary outcomeStudy armsPrincipal investigatorInstitutional review boardClinical trialsTrial initiationCOVID-19-related issuesBest practicesPainSample sizeReview boardSafety monitoring boardOutcomesTrialsRecommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory
Dziura J, Gilstad-Hayden K, Coffman C, Long C, Yu Q, Buta E, Coggeshall S, Geda M, Peduzzi P, Kyriakides T. Recommendations for monitoring adherence and fidelity in pragmatic trials based on experience in the Pain Management Collaboratory. Pain Medicine 2024, 25: s41-s48. PMID: 39514878, PMCID: PMC11548857, DOI: 10.1093/pm/pnae080.Peer-Reviewed Original ResearchConceptsPain Management CollaboratoryPragmatic trialPragmatic Explanatory Continuum Indicator SummaryMonitor adherenceElectronic health recordsFidelity dataIntervention deliveryIntervention fidelityIndicator SummaryHealth recordsTrial interventionProtocol adherenceParticipant engagementStudy teamAdherence dataAdherenceTrial integrityInterventionParticipantsSafety monitoring boardFrequent sourcePainLevel of monitoringTrialsMonitoring boardAchieving two-part harmony: standardizing pain-related phenotypes and outcomes
Edwards R, Geda M, Burgess D, Davis A, DeBar L, Pal N, Peduzzi P, Taylor S, Wallace R, Luther S. Achieving two-part harmony: standardizing pain-related phenotypes and outcomes. Pain Medicine 2024, 25: s7-s10. PMID: 39514875, PMCID: PMC11548856, DOI: 10.1093/pm/pnae069.Peer-Reviewed Original ResearchUtility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory
Peduzzi P, Brandt C, Dearth C, Dziura J, Farrokhi S, George S, Kyriakides T, Long C, Mascha E, Patterson C, Rhon D, Kerns R. Utility of the PICOTS framework to assess clinical trial disruptions: monitoring the impact of COVID-19 in the Pain Management Collaboratory. Pain Medicine 2024, 25: s34-s40. PMID: 39514876, PMCID: PMC11548861, DOI: 10.1093/pm/pnae078.Peer-Reviewed Original ResearchConceptsPain Management CollaboratoryPICOTS frameworkIndividual-level randomizationPain management researchPragmatic clinical trialsIntervention fidelityCare deliveryStepped-wedgeSpecialty careClinical partnersCOVID-19 experienceIn-personPain managementOutcome assessmentStudy designCOVID-19Nonpharmacologic approachesImpact of COVID-19PICOTExperimental interventionLead investigatorsTrial designDesign of clinical trialsAffective deliveryPainIntroduction: Pain Management Collaboratory: updates, lessons learned, and future directions
Kerns R, Brandt C, Peduzzi P. Introduction: Pain Management Collaboratory: updates, lessons learned, and future directions. Pain Medicine 2024, 25: s1-s3. PMCID: PMC11548851, DOI: 10.1093/pm/pnae097.Peer-Reviewed Original ResearchAssessing readiness to use electronic health record data for outcome ascertainment in clinical trials – A case study
Esserman D, Greene E, Latham N, Kane M, Lu C, Peduzzi P, Gill T, Ganz D. Assessing readiness to use electronic health record data for outcome ascertainment in clinical trials – A case study. Contemporary Clinical Trials 2024, 142: 107572. PMID: 38740298, DOI: 10.1016/j.cct.2024.107572.Peer-Reviewed Original ResearchElectronic health record dataElectronic health recordsOutcome ascertainmentDevelop Confidence in EldersElectronic health record platformsClinical sitesPrimary care practicesHealth record dataMulti-site trialMulti-site clinical trialCare practicesHealth recordsAssess readinessAcute clinical outcomesHealthcare systemRecord dataClinical trialsReduce injuriesData qualityData comprehensionChecklistStudy dataClinical trial sitesVariable data qualityAscertainmentValidation of a Rule-Based ICD-10-CM Algorithm to Detect Fall Injuries in Medicare Data
Ganz D, Esserman D, Latham N, Kane M, Min L, Gill T, Reuben D, Peduzzi P, Greene E. Validation of a Rule-Based ICD-10-CM Algorithm to Detect Fall Injuries in Medicare Data. The Journals Of Gerontology Series A 2024, 79: glae096. PMID: 38566617, PMCID: PMC11167485, DOI: 10.1093/gerona/glae096.Peer-Reviewed Original ResearchFee-for-serviceFall injuriesMedicare AdvantageMedicare dataTrial armsHealthcare systemDevelop Confidence in EldersArea under the receiver operating characteristic curveMedicare fee-for-serviceStratified resultsMedicareReduce injuriesMedical attentionObservational studyStrideReceiver operating characteristic curveCalendar monthMA dataInjuryData sourcesHealthcareArmReference standardTrialsWindow sizeThe dementia care study (D‐CARE): Recruitment strategies and demographic characteristics of participants in a pragmatic randomized trial of dementia care
Yang M, Samper‐Ternent R, Volpi E, Green A, Lichtenstein M, Araujo K, Borek P, Charpentier P, Dziura J, Gill T, Galloway R, Greene E, Lenoir K, Peduzzi P, Meng C, Reese J, Shelton A, Skokos E, Summapund J, Unger E, Reuben D, Williamson J, Stevens A. The dementia care study (D‐CARE): Recruitment strategies and demographic characteristics of participants in a pragmatic randomized trial of dementia care. Alzheimer's & Dementia 2024, 20: 2575-2588. PMID: 38358084, PMCID: PMC11032530, DOI: 10.1002/alz.13698.Peer-Reviewed Original ResearchElectronic health recordsPragmatic clinical trialsRecruitment strategiesDementia careApproaches to dementia careDementia care studiesCommunity-dwelling dyadsDyads of personsDiagnosis of dementiaHealth system patientsDemographic characteristics of participantsPragmatic randomized trialCharacteristics of participantsPragmatic research studiesFamily caregiversHealth recordsHealth systemCare studiesPLWDSystem patientsDemographic characteristicsD-CAREDementiaCaregiversClinical trial sites
2023
Unresolved issues with noninferiority pragmatic trials: Results of a literature survey
Ciarleglio M, Li J, Peduzzi P. Unresolved issues with noninferiority pragmatic trials: Results of a literature survey. Clinical Trials 2023, 21: 242-256. PMID: 37927102, DOI: 10.1177/17407745231206371.Peer-Reviewed Original Research